Javelin Pharmaceuticals, Inc.

Javelin Pharmaceuticals, Inc. is a specialty healthcare company that applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs that target unmet and underserved medical needs in pain management. Seeking to develop differentiated moderate-to-severe pain control products, Javelin aims to overcome the limitations of existing prescription pain medications. Indications under development include post-operative pain, orthopedic injury pain, procedural pain, burn pain and trauma. Product candidates offer enhanced pain relief, fewer adverse side effects, and faster relief of pain compared to other currently available treatments.

Javelin has three late stage product candidates in development: Dyloject^TM (diclofenac sodium, injectable), Rylomine^TM (intranasal morphine), and PMI-150 (intranasal ketamine). All three late stage development product candidates utilize different proprietary technologies to deliver patient benefit.

Currently available formulations of the popular drug diclofenac are insoluble in water. Javelin has successfully improved the solubility of diclofenac by the addition of hydroxypropyl-beta-cyclodextrin (HPßCD), allowing for the creation of a proprietary injectable formulation that can efficiently deliver the drug to the patient's bloodstream. Cyclodextrins, such as HPßCD, are ring-shaped carbohydrate molecules that can improve the solubility of poorly soluble drugs such as diclofenac. While there are many types of cyclodextrins, most are systemically toxic. Only modified cyclodextrins are regarded as safe for injection. Javelin's HPßCD, called Dyloject^TM, is used in higher concentrations in the FDA-approved injectable antifungal drug, Sporanox®.

Morphine, like many drugs, is poorly absorbed across mucosal barriers and, in particular, the nasal membrane. Javelin has a proprietary technology that allows for nasal delivery of predictable therapeutic blood levels of morphine. The key to this technology is ChiSys^TM, a carbohydrate polymer that, while pharmaceutically inert by itself, enhances the absorption of compounds across mucosal membranes such as those found in the nasal cavity. Javelin's contribution of ChiSys^TM to enhancing mucosal drug absorption, which it calls Rylomine^TM, reflects several factors including its potent mucoadhesive property which prevents drug washout.

Ketamine is an FDA-approved anesthetic agent for intravenous or intramuscular administration. It is the anesthetic agent of choice for use in trauma because of its favorable safety profile. The use of low dose ketamine as a pain medication has been reported in the medical literature and while not yet approved by the FDA, is gaining clinician acceptance due to its effectiveness for treating neuropathic pain and minimal impairment of cardiovascular and respiratory functions. Javelin has successfully developed PMI-150, a proprietary nasal formulation that can safely deliver subanesthetic blood levels of ketamine using a method of administration ideally suited as a pain medication.

Cat Trail participated in the company's recent direct equity offering.

For additional information, visit the company website at javelinpharmaceuticals.com